The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )

NCT ID: NCT05894733

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-11-01

Brief Summary

The investigators planned to investigate the effect of close monitoring on compliance and the factors affecting compliance among patients receiving PAP treatment due to OSA.This study was a single-center, prospective, randomized, controlled study approved by the hospital's ethics committee.One hundred twenty-eight patients were randomized as group one or two as group 1 is the study and group 2 is the control group. The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.

The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months. The patients who came to the control were asked if there were any problems with the device and any difficulties in use, and they were again informed about the devices and masks.

Conditions

Patient Compliance; Sleep Disorder; Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

1

1: The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.

Group Type: OTHER

study group

Intervention Type: OTHER

Calling with phone frequently(15.th day, 1 month , 3 month, 6 month ) and face to face interwiew on first, 3 th and 6th month

2

2:The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months

Group Type: OTHER

control group

Intervention Type: OTHER

first and sixth month face to face interwiew

Interventions

study group

Calling with phone frequently(15.th day, 1 month , 3 month, 6 month ) and face to face interwiew on first, 3 th and 6th month

Intervention Type: OTHER

control group

first and sixth month face to face interwiew

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

. unfollowed patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Makbule Özlem Akbay

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

makbule özlem akbay, md

Role: PRINCIPAL_INVESTIGATOR

sureyyapasa chest diseases center

Locations

Makbule Özlem

Maltepe, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id